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TGA Suspends Ranitidine Medicines Ahead of Possible License Cancellations

The Therapeutic Goods Administration (TGA) has suspended 23 ranitidine medicines from the Australian Register of Therapeutic Goods (ARTG). TGA suspended the products for six months but thinks there are grounds to ultimately cancel the medicines from the ARTG altogether.

Last month, TGA presented results from tests on 34 ranitidine medicines sold by 10 companies. The tests, which covered 135 batches, suggested most ranitidine medicines available in Australia contained more than 0.3 parts per million (PPM) of N-nitrosodimethylamine (NDMA), meaning they breached the internationally agreed limit for the carcinogen. Back then, TGA said it was considering “suspending the registration for products which cannot demonstrate adequate safety and quality.”

Now, TGA has revealed its response to the high levels of NDMA. The Australian regulator has put 23 ranitidine medicines on a six-month suspension that will run from 16 December to 16 June. Apotex, Arrow Pharma and Sandoz are among the companies with products affected by the suspension.

Ranitidine products absent from the list of suspended medicines include two ARTG entries sold by Arrow Pharma under the Chemists’ Own brand. The products were two of five ARTG entries with batches TGA found to contain levels of NDMA below 0.3ppm. Batches taken from two other Arrow Pharma ARTG entries and one Sandoz entry also passed the TGA test but were still suspended.

TGA uses suspensions to protect patients while giving manufacturers the chance to address issues with their products. In the case of the ranitidine medicines, if the affected companies fail to make changes to reassure TGA of the safety of their products, they face the prospect of losing their place on the ARTG permanently.

In the section on the grounds for suspension for each of the 23 products, TGA wrote that, “It is likely there are grounds for cancelling this medicine from the ARTG … on the basis that the quality of the goods is unacceptable.” The affected manufacturers now have a little more than six months to stop that happening, although in some cases TGA extends suspensions to give companies more time to fix problems with their products

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